Corporate History

1999: A Year of Discovery Results in A New Company that Focuses on Improving the Quality of Treatment Decisions for Patients with Cancer.

• Future Genomic Health® CEO Randy Scott's experience with a close friend who was diagnosed with cancer brings the realization that despite all the research to map and understand the human genome, there is little being done to help patients get the best care based on the molecular make-up of their specific tumor. The frustration of watching a close friend grapple with cancer creates the inspiration for Genomic Health, a company focused on improving the quality of treatment decisions for patients with cancer.

2000: Personalized Breast Cancer Test Studies and Diagnostics for Patients in Need of Cancer Treatment Options Spurs Development of Genomic Health.

• Randy leaves his current company, Incyte, to start Genomic Health, with the goal of developing high-value diagnostics to enable more personalized cancer treatment decisions based on the genomic activity within a patient's individual tumor. In a week's time, he pulls together a rough draft business plan for Genomic Health, targeting ways to improve the quality of cancer treatment decisions.

• Randy takes the plan to his mentor and PhD thesis advisor, Joff Baker, for advice. Joff is enthusiastic and suggests consulting his Genentech colleague, Steve Shak, based on Steve's experience leading the Herceptin clinical program.
• Randy lines up the first employee, Gene Early (an organizational health consultant), and they begin working from his pool-house to develop a business plan and organization that supports the role of genomic analysis in driving personalized medicine.

• With Gene, Joff and Steve on board, Randy and team recruit patient advocacy expert, Pat Terry, and a founding team is ready to go to work!

• The company completes series A funding, raising $7.9 million from family and friends of the founders.

2001: Genomic Health Makes Great Strides in Proof of Concept.

• The company sets up a lab in an incubator space at the Alameda Naval Air Station.
• The company completes series B funding with the primary investors Baker-Tisch; Kleiner, Perkins, Caufield & Byers; and Versant, helping to raise an additional $29 million.

• The company completes series C funding, raising an additional $5 million from Incyte.
• The company has developed an RNA extraction protocol for archived formalin fixed paraffin embedded tissue, and profiles gene expression by reverse transcription polymerase chain reaction (RT/PCR). This same technology is utilized both for product development and for generation of clinical test data in the commercial laboratory.

• The company selects TaqMan RT-PCR as its core expression profile technology.

• The company settles in Redwood City, California.
• A proof of concept is completed, confirming the company's ability to successfully obtain gene expression analysis profiles from formalin-fixed paraffin-embedded (FPET) tumor tissue.

• The company approaches multiple clinical collaborators, including the NCI cooperative group, National Surgical Adjuvant Breast and Bowel Project (NSABP) about collaborating to transform the way cancer is treated.

• Genomic Health signs an agreement with NSABP to access its archived tissue blocks for the company's clinical studies.

2002: Genomic Health Welcomes New COO; Breast Cancer Diagnostic Testing Efforts Begin Building Steam.

• Kim Popovits joins as President and COO to build the company's commercial operation.

• The management team decides to target early stage, node negative, estrogen-receptor positive breast cancer for its first diagnostic test.
• The company completes series D funding, raising an additional $9.3 million.

2003: Genomic Health Presents Gene Expression Analysis Studies at ASCO and SABCS; Company Continues to Grow.

• Initial gene expression analysis studies are completed, demonstrating that certain genes found in breast cancer tissue can help predict which patients will survive.

• Genomic Health and clinical collaborators present four studies at the American Society of Clinical Oncology (ASCO) Annual Meeting, which examined breast cancer recurrence, response to chemotherapy in breast cancer and a panel of genes associated with response to EGFR inhibitor therapy in lung cancer patients. The following press release provides more details about breast cancer test studies and the ASCO presentation.
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• The company hires its first Regional Oncogenomic Liaison (ROL) or sales representative.

• The company finalizes the parameters for its first breast cancer assay and completes lab preparation.

• Genomic Health and NSABP initiate the B14 recurrence validation study.

• B14 validation study is completed and the results meet defined end points.

• The company successfully completes its CLIA (Clinical Laboratory Improvement Amendments) lab inspection.

• Genomic Health and NSABP present positive results from the B14 recurrence validation study at the San Antonio Breast Cancer Symposium (SABCS).The following press release details Genomic Health's breast cancer test presentation at SABCS.
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2004: A Year of Introduction, Recognition and Results Impacts Patients in Need of Improved Cancer Treatment Decisions.

• CLIA certifies the Genomic Health clinical laboratory to perform and offer the company's first breast cancer assay, Oncotype DX^®.
• The first commercial tumor sample arrives at Genomic Health.
• The first Oncotype DX Breast Cancer Assay patient report is generated and shipped from Genomic Health's lab.

• The company conducts it first advisory board to introduce the Oncotype DX breast cancer test to the physician community.

• Genomic Health and Instituto Nazionale Tumori announce preliminary results from an initial chemotherapy response study at the annual ASCO meeting; ASCO selects the B14 validation study for its "Best of Oncology" special session.The following press release provides details about the breast cancer test.
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• Kaiser Permanente presents results from a study confirming Oncotype DX breast cancer assay's clinical validity in a community setting at SABCS. The following press release provides more information about the test for breast cancer.
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• Genomic Health and NSABP present positive results from the B20 chemotherapy benefit study at SABCS; the New England Journal of Medicine publishes the B14 recurrence validation study online as an "early release" to coincide with SABCS data presentations about the test for breast cancer. The following press release provides more information about the breast cancer assay.
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• In the days following SABCS, the company receives up to 200 calls per day and the number of breast cancer assays ordered triples.

2005: Company Announces Initial Public Offering.

• The College of American Pathologists (CAP) accredits the Genomic Health clinical laboratory.

• An economic analysis modeling the cost-effectiveness of the Oncotype DX breast cancer assay is published in the American Journal of Managed Care. The following press release provides more details about the breast cancer test.
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• Genomic Health presents multiple studies at ASCO that support Oncotype DX's ability to predict chemotherapy benefit and capture prognosis and response to tamoxifen; ASCO selects the B20 chemotherapy response study for its "Best of Oncology" special session. The following press release provides more information about the breast cancer test selected for presentation by ASCO.
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• Genomic Health goes public, raising more than $60 million through an initial public offering of 5,016,722 shares of Common Stock valued at $12.00 per share.The following press release provides more information about the initial public offering.
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• The Journal of Clinical Oncology (JCO) publishes the Instituto Nazionale Tumori chemotherapy response study of the breast cancer test. The article in the Journal of Clinical Oncology details the study's findings.
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• The company conducts its first conference call as a public company to announce third quarter 2005 financial results. The following press release provides more details about advancing strategy to provide critical information that enables more informed cancer treatment decisions.
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• Genomic Health and the Rocky Mountain Cancer Center present results of a community-based study at SABCS indicating that the Oncotype DX breast cancer assay can change adjuvant treatment decisions for 25% of patients. The following press release provides more information about the breast cancer test.
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• Genomic Health presents two studies at SABCS demonstrating Oncotype DX's ability to quantify risk for local and regional recurrence, and provide robust results on small tumor specimens. The following press release provides details about the breast cancer assay.
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2006: Medicare Establishes Reimbursement for the Oncotype DX Breast Cancer Assay.

• Medicare establishes reimbursement for Oncotype DX breast cancer assay. The following press release provides more information about the reimbursement policy for the breast cancer test.
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• The Journal of Clinical Oncology (JCO) publishes the B20 chemotherapy benefit study online as an "early release" to coincide with the launch of NCI's landmark clinical trial, TAILORx. The following press release provides details about the study published in JCO, which confirms the Oncotype DX test for breast cancer predicts the likelihood of response to chemotherapy in a large portion of women with early-stage breast cancer. The breast cancer assay is discussed in further detail in the JCO publication.
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• Breast Cancer Research publishes the Kaiser Permanente community-based study of Oncotype DX. The following press release provides information about the publication of the landmark Kaiser Permanente study demonstrating the Oncotype DX breast cancer assay helps predict likelihood of survival in early-stage breast cancer. The publication provides full detail of the Oncotype DX breast cancer assay study results.
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• Genomic Health and NSABP present results from the first colon cancer study at ASCO demonstrating a correlation between gene expression and disease recurrence, prompting additional studies for the development of a colon cancer test. The following press release provides information about the study's findings, which indicate that an Oncotype DX test service may improve treatment decisions for patients seeking treatment for colon cancer.
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• The U.S. Food and Drug Administration (FDA) issues draft guidance on the potential regulation for In Vitro Diagnostic Multivariate Index Assays, or IVDMIAs. The following press release provides more information.
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• Aetna establishes a national reimbursement contract for the Oncotype DX breast cancer assay, covering more than 15 million lives. The following press release provides details about Aetna's contract for breast cancer test services.
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• Genomic Health and NSABP present results at SABCS demonstrating the precision of the Oncotype DX breast cancer assay in measuring estrogen receptor (ER) status. The following press release provides information about the study results.
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2007: Breast Cancer Test Goes Global; Breast Cancer Test Services Provided Worldwide.

• The company moves its colon cancer assay research program into full clinical development. The following press release provides details about how patients seeking colon cancer treatment may benefit from improved treatment decisions.
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• UnitedHealthcare establishes a national reimbursement contract for Oncotype DX breast cancer test services. The following press release provides information about the insurance company contract for breast cancer test.
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• Genomic Health signs an exclusive agreement with Medical Solutions to distribute the Oncotype DX breast cancer test in the United Kingdom. The following press release provides full details about the agreement to distribute the test in the UK.
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• Loyola University Health System presents results from an independent prospective multi-center trial that found the Oncotype DX test for breast cancer impacts treatment decisions for physicians and patients. The following press release provides details about the study.
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• Genomic Health presents positive results at ASCO from its first study investigating the Oncotype DX breast cancer assay in node-positive breast cancer patients. The following press release provides more information about the breast cancer test results.
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• The Journal of Oncology Practice publishes the Rocky Mountain Cancer Center's community-based treatment impact study of the Oncotype DX breast cancer assay. The publication provides extensive details about the breast cancer test study.
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• Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) issues a positive assessment for the use of the Oncotype DX breast cancer assay to inform decision-making about adjuvant chemotherapy treatments for breast cancer. The following press release provides additional details about the assessment.
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• Genomic Health presents results from three studies at the ASCO Breast Cancer Symposium that support the use of quantitative real-time polymerase chain reaction (RT-PCR), as performed in the Oncotype DX breast cancer assay, for quantifying the hormone receptors estrogen receptor (ER) and progesterone receptor (PR) in breast cancer. The following press release provides more information about the breast cancer test studies.
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• ASCO includes the Oncotype DX breast cancer assay in its updated guidelines on the use of breast cancer tumor markers. The following press release provides more information about ASCO's breast cancer guidelines. The guidelines published by ASCO provide more detail about the usage of tumor markers in the treatments of breast cancer.
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• The Southwest Oncology Group (SWOG) presents positive results from a study of Oncotype DX breast cancer tests in postmenopausal women with node-positive, hormone receptor positive breast cancer at SABCS.
• Genomic Health announces results from eight Oncotype DX breast cancer test studies presented at SABCS providing additional insights into the impact on treatment options for patients seeking treatments for breast cancer and quantitative single gene expression reporting, as well as new information on node-positive breast cancer. The breast cancer assay studies presented at SABCS are detailed in the press release.
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2008: Company Continues to Move Forward, Begins Offering Oncotype DX Breast Cancer Test Ordering and Results Online.

• The National Comprehensive Cancer Network (NCCN) includes Oncotype DX in its 2008 Breast Cancer Treatment Guidelines. Learn more about the breast cancer assay in a press release. The NCCN Treatments for Breast Cancer Guidelines are available online.
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• Genomic Health and Pfizer initiate a collaboration to develop a prognostic test to estimate the risk of recurrence for patients with non-metastatic renal cell carcinoma. The following press release provides more information.
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• Genomic Health presents results from two studies at the ASCO Gastrointestinal Cancers Symposium identifying genes that could help predict the likelihood of colon cancer recurrence and chemotherapy benefit for early-stage colon cancer. The following press release provides more information about the likelihood of colon cancer recurrence and potential chemotherapy benefits.
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• The company begins including quantitative ER and PR scores on all Oncotype DX patient reports.

• The Journal of Clinical Oncology published results of a study demonstrating the validity of Oncotype DX in measuring quantitative gene expression for ER and PR status, indicating that quantitative RT-PCR, as performed in the Oncotype DX breast cancer assay, is a reliable method for determining hormone receptor status in breast cancer. The publication provides more information about the test for breast cancer.
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• Genomic Health presents results from two separate studies with collaborators at ASCO identifying genes that could potentially predict benefit from certain targeted therapies and treatments for breast and colon cancers. The following press release offers more details about the predicted benefits for patients seeking treatment of colon cancer and breast cancer.
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• The Journal of Clinical Oncology published results of a study comparing Oncotype DX to Adjuvant! Online computer-based algorithm.
• Genomic Health announces results of two studies supporting the use of Oncotype DX breast cancer tests to measure HER2 status at the ASCO Breast Cancer Symposium.

• Genomic Health presents results from large, European study establishing utility of Oncotype DX breast cancer assay in node-negative and node-positive breast cancer patients treated with Aromatase Inhibitors at the 31st annual San Antonio Breast Cancer Symposium (SABCS). The following press release provides more information about the European breast cancer test study.
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• Genomic Health launches Online Ordering - a new application that allows physicians to order, see status, and receive Oncotype DX breast cancer test results online.

2009: Company Makes Great Strides in Colon Cancer Assay Validation Studies.

• Genomic Health announces the initiation of an independent clinical validation study for its 18-gene Oncotype DX Colon Cancer Assay. The following press release offers more details about the study's findings related to the colon cancer assay.
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• Genomic Health announces the appointment of Kimberly J. Popovits as Chief Executive Officer. The following press release provides more information about the appointment.
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• Genomic Health Announces Positive Preliminary Results from QUASAR Colon Cancer Validation Study of Oncotype DX colon cancer assay. The following press release offers more information about how the validation study may predict the likelihood of recurrence for stage II colon cancer patients following surgery.
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• Genomic Health announces positive results from its first Japanese study, confirming the Oncotype DX Recurrence Score^® accurately predicts the likelihood of breast cancer recurrence in a specific ethnic population. The following press release offers more information about the breast cancer assay study.
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• Genomic Health announces the presentation of full results from the landmark QUASAR validation study of its Oncotype DX® colon cancer assay test at ASCO. The following press release provides more detail about the colon cancer assay test study.
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• Genomic Health presents results from the first study of Oncotype DX® Breast Cancer test in male patients at ASCO. The following press release provides more information about the company's breast cancer tests for men.
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• Genomic Health announces that the Oncotype DX Breast Cancer test has helped guide individualized treatment decisions for more than 100,000-breast cancer patients worldwide. The following press release provides more information about the breast cancer test impacts.
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• Genomic Health reports favorable commentary on the value of multigene tests from the St. Gallen expert consensus meeting on the primary treatment of early breast cancer. The following press release provides more details about the impact of the tests on diagnostics for patients in need of treatments for breast cancer.
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• Genomic Health presents data confirming the consistent distribution of the Oncotype DX Recurrence Score across European, Middle Eastern and U.S. patient populations, at the joint ESMO/ECCO Multidisciplinary Congress. The following press release offers more information about the breast cancer tests.
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• Genomic Health presents data confirming manual microdissection of biopsy cavities is essential for accurate recurrence risk assessment in early-stage breast cancer patients, at the American Society of Clinical Oncologists (ASCO) Breast Cancer Symposium. The following press release provides more information about the critical role of the Onctotype DX breast cancer test.
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• Genomic Health presents five new studies at the San Antonio Breast Cancer Symposium (SABCS), reinforcing clinical utility of Oncotype DX in multiple breast cancer populations. The following press release explains how the test for breast cancer may impact patients' treatment decisions.
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• The Lancet Oncology publishes a study of Oncotype DX node-positive breast cancer that identifies patients who do not appear to benefit from chemotherapy. The following press release provides more information about how the Oncotype DX breast cancer test can help predict chemotherapy benefit in breast cancer patients with node-positive disease.
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2010: Genomic Health Begins New Decade by Making Colon Cancer Assay Test Available Worldwide.

• Genomic Health announces worldwide availability of the Oncotype DX colon cancer assay test. The following press release provides more information about the impacts of the test on the assessment of risk of colon cancer recurrence.
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• Genomic Health signs an exclusive agreement with Palex Medical S.A. to distribute the Oncotype DX test in Spain and Portugal. The following press release provides additional information about the Genomic Health Palex partnership.
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• Genomic Health presents results demonstrating the successful whole genome expression and mutation analysis from formalin fixed, paraffin-embedded tumor samples, at the 11th Annual Advances in Genome Biology and Technology (AGBT) meeting in Marco Island, Florida. The following press release provides additional information about the whole genome expression and mutation analysis.
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• Genomic Health presents results at the 27th Annual Miami Breast Cancer Conference demonstrating that ribonucleic acid (RNA) extraction and reverse transcription polymerase chain reaction (RT-PCR) technology can be successfully performed to assess gene expression profiles from formalin fixed paraffin embedded ductal carcinoma in situ (DCIS) patient samples. These findings indicate that it is feasible to obtain Oncotype DX Recurrence Score^® results in DCIS patients.

• The Journal of Clinical Oncology (JCO) publishes positive results from a large international study which demonstrated that the Oncotype DX breast cancer Recurrence Score result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive, postmenopausal breast cancer patients who are treated with either anastrozole or tamoxifen. The following press release provides more information about the JCO publication.
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• Genomic Health announces the presentation of six new studies including four oral presentations in breast, colon and renal cancers at American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The following press release provides more detail about the six studies, including results from a collaboration with Pfizer Oncology for assessing prognosis for early-stage renal cell carcinoma.
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